Pure Global

Bio-Check EBV EA+EBNA-1 IgA ELISA Kit - HSA Registration DE0011902

Access comprehensive regulatory information for Bio-Check EBV EA+EBNA-1 IgA ELISA Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0011902 and owned by BIO-CHECK LABORATORIES LTD. The device was registered on December 20, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0011902
Bio-Check EBV EA+EBNA-1 IgA ELISA Kit
HSA Registration Number: DE0011902
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

It is an enzyme linked immunosorbent assay intended for the qualitative or quantitative detection of IgA antibodies against the early antigen and nuclear antigen of the Epstein-Barr virus contained in human serum

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
HSA Product Code
HSAMDC00106
HS Code
38220090
Registration Information
Registration Number
DE0011902
Registration Date
December 20, 2012
Retention Due Date
December 19, 2025
Product Owner
Short Name
BIO-CHECK LABORATORIES LTD
Address
10F, No 8 Lane 348, Sec 2,, Chung-Shan Road, Chung-Ho, Taipei,, taiwan 235, TAIWAN
Registrant
Address
300 TAMPINES AVENUE 5, INCOME AT TAMPINES JUNCTION, #09-02, SINGAPORE 529653
Importer
Address
239B VICTORIA STREET, SINGAPORE 188029
Model Information
Model Name(s)
Substrate A Substrate B Conjugate Conjugate Diluent Serum Diluent Stop Solution Control A Control B Control C Negative Control 20X Conc.Washing Solution ELISA PLATE EBV EA+EBNA-1 IgA ELISA kit
Model Identifier(s)
EB9601 EB9602 EB9603 EB9604 EB9605 EB9606 EB9607 EB9608 EB9609 EB9610 EB9611 EB9612 EBV EA+EBNA-1